Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Title | Prävention des postoperativen endoskopischen Krankheitsrückfalls bei Morbus Crohn |
Participants (P) |
Adult patients with Crohn’s disease recently undergoing an ileocolonic resection with ileocolonic anastomosis. Patients with at least 1 risk factor for postoperative recurrence: active smoking, penetrating disease, previous ileocolonic resection ≤10 years, ≥2 previous ileocolonic resections, or biological therapy ≤3 months of resection The ileocolonic resection should have been curative (concomitant small bowel stricture plastic allowed) |
Intervention (I) |
Endoscopy-driven postoperative biological therapy: No CD related therapy will be administered between Baseline and the endoscopic evaluation at week 30 Patients with endoscopic recurrence (Rutgeerts score ≥i2b) at week 30 will initiate biological therapy (adalimumab, infliximab, ustekinumab or vedolizumab) following a classical induction and maintenance schedule |
Control (C) |
Systematic postoperative prophylaxis with a biological: Biological therapy (adalimumab, infliximab, ustekinumab or vedolizumab) will be initiated within 14 to 40 days after restoration of the faecal stream (Baseline) In patients with both Harvey-Bradshaw index (HBI) based clinical recurrence (HBI >4) and endoscopic recurrence (Rutgeerts score ≥i2b) at week 30, biological therapy will be optimized (reimbursed or through the available free goods programs) |
Outcome (O) |
Endoscopic recurrence (Rutgeerts score ≥i2b) at week 86 or need for unscheduled treatment adaptation prior to week 86 |
Trial Design |
This will be a prospective, randomized, parallel group, pragmatic trial. |
Sample Size |
352 |
Trial duration |
80 Months for primary end points + 3 Years of long-term follow-up |
First patient in | Q2 2021 |
Trial Report | Q1 2029 |
Budget |
3.45M € |
Sponsor |
UZ Leuven |
Chief Investigator |
Prof. Dr. Ferrante |
External Partners |
NAP |
Number of Participating Sites |
28 sites |
Protocol | click here |
Report | Q2 2028 |
Publication |
Clinicaltrials.gov: NCT05169593